For more than 15 years NICE has punched above its weight internationally but as it comes under attack for its methodology, will its international clout suffer?

The bad headlines are back; on 20 May, the National Institute for Health and Care Excellence (NICE) once again came under fire from the media for its decision to bar Roche's Perjeta (pertuzumab) for breast cancer from the NHS. The issue is particularly fraught because, in July, NICE will take back responsibility for decisions on all NHS cancer treatments, after the Cancer Drugs Fund is wound up. While patient groups and charities are worried about the effect on cancer patients in England, who may be denied treatment, there may also be a knock-on effect in other countries, which still look to NICE for guidance over their own reimbursement decisions.

NICE's international influence has always been strong. As one of the pioneers of health technology assessment (HTA) when it was first set up in 1999, it brought new rigour to decisions about the use of drugs, equipment and other treatments. Although quality-adjusted life years (QALY) were far from being its invention, it promoted their use as a basis for decisions about cost-effectiveness. Over the next decade or so, as policymakers swapped notes at international conferences and in international HTA groups, NICE-style methods spread. Meanwhile, other, mostly poorer, countries simply adopted some NICE decisions wholesale, because it was cheaper than setting up their own HTA agency.

It was a role that NICE embraced with the establishment of NICE International, which advises countries from Ghana to Kazakhstan on HTA methodology and implementation. NICE is also working with governments in Asia, for example, on efforts to improve access to healthcare without soaring spending. Its Clinical Pathways programme in China is one of the key elements in that country's reforms of its public hospitals. In India, NICE is helping with the (somewhat delayed) rollout of the country's universal
healthcare system.

Yet, its international spread has come hand-in-hand with the growing disillusionment about NICE's decisions. After all, the Cancer Drugs Fund was set up in 2010 precisely because NICE decisions were so controversial and became a big issue in that year's general election, leading the winning coalition government to find a way to pay for some cancer drugs that failed cost-effectiveness tests. The Fund's life was extended time and again, although it came in for flak for overspending, therefore diverting money away from other areas of treatment.

Internationally, too, NICE methodology has been under fire for years. An IMS Institute study in 2013 compared the reimbursement of cancer drugs in five countries that used cost per QALY methodologies, including the UK, with five using broader methodologies, including Germany and US. It found that the cost per QALY countries reimbursed fewer cancer drugs, had slower access to those they did adopt, and generally performed poorer in terms of cancer outcomes. Moreover, it was not clear that they saved much money.

Those findings were supported by an EU-funded study, ECHOUTCOME, the same year, which concluded that the QALY was a flawed measure. Although NICE defended the methodology at the time, it clearly helped to prompt the agency to launch a three-month consultation process in 2014. Although it failed to come to a definitive conclusion, NICE has broadened its methodology slightly, particularly for end-of-life care.

Bringing cancer spending back under NICE's control, therefore, seems like a sensible compromise. In February, the government finally decided to do just that from July, with an additional provision covering particularly promising drugs for two years while they are evaluated. This has not prevented the bad headlines from re-emerging, yet Roche can worry less about knock-on effects from NICE's decision on Perjeta. Although the company was quick to protest about the potential effect on English patients, sales of the drug were up 33 percent year on year in the first quarter of this year, suggesting that plenty of countries do see it as cost-effective.